Avadel Pharmaceuticals plc

Good morning. My name is Rob and I will be your conference operator today. At this time, I would like to welcome everyone to the Avidel Pharmaceuticals third quarter 2022 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you'd like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, again press the star one. Thank you. Austin Murtaugh from Avidel Investor Relations. You may begin your conference.

Good morning, and thank you for joining us on our conference call to discuss third quarter 2022 earnings. As a reminder, before we begin, the following presentation includes several matters that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These risks include risks that products in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements, uncertainties regarding market entry and acceptance of products, and the impact of competitive products and pricing. These and other risks are described more fully in Avidel's public filings under the Exchange Act included in the Form 10-K for the year ended December 31st, 2021, which was filed on March 16, 2022, and subsequent SEC filings. Except as required by law, Avidel undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events, or otherwise. On the call today are Greg Divis, Chief Executive Officer, Jennifer Goodman, Vice President of Medical and Clinical Affairs, Richard Kim, Chief Commercial Officer, and Tom McHugh, Chief Financial Officer. At this time, I'll turn the call over to Greg.

Thank you, Austin. Good morning, everyone, and thank you for joining us this morning to discuss Avidel's third quarter 2022 results. Q3 was another important quarter for Avidel in our pursuit to bring LumeRise to people with narcolepsy. Most importantly, LumeRise, our investigational once-at-bedtime oxibate therapy, for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy was granted tentative approval by the FDA in July. The FDA's formal decision of granting tentative approval results in three very important developments for Avidel. First, it validates Lumerize's safety profile and clinical efficacy and, as such, has confirmed that Lumerize is approvable as a once-at-bedtime therapy. We view this as a major regulatory de-risking event for Avidel. Second, it enables us to complete work on key launch-related activities, including the build-out of the REMS program and the manufacture of commercial launch supply. We've made significant progress in these activities in Q3 and are on track to have both completed before the end of the year. Lastly, it confirms that the potential latest date we should receive a final approval decision is after expiry of the REMS patents. which will occur on June 17, 2023, approximately seven months from now. A final approval would then be followed by a launch that is expected no later than Q3 of 2023 into what we believe is a $3 billion-plus market opportunity. We will continue to take the necessary actions to bring Lumerize to final approval and, more importantly, to provide access to people with narcolepsy who are desperately seeking new treatment options. Very recent comprehensive market research that Richard will highlight shortly continues to confirm the significant interest in Lumerize across all patient and physician segments, all of which is supported further by what we see in the real-world data coming from our RESTORE study, where 94% of twice-nightly switch patients prefer the once-at-bedtime dosing of Lumerize. The combination of the real-world data of RESTORE along with our extensive market research and data analytics, confirms our belief that Lumerize is well-positioned to capture a meaningful share of the projected $3 billion-plus once-at-bedtime Oxibate market. Although our base case assumption is to receive a final approval decision following expiration of the REMS patent in June of 2023, we continue to pursue efforts that could potentially lead to a final approval decision sooner. More specifically, the Delaware Court has granted our expedited request and has scheduled a hearing on our renewed motion to delist the REMS patent from the Orange Book for next week on Tuesday, November 15th at 10 a.m. Eastern Time. We look forward to the Delaware Court's decision and the opportunity to potentially accelerate the timeline to a final approval and subsequent launch for Lumeron's. With that, I'll turn the call over to Jennifer to provide details on our recent data presentations. Jennifer?